Aseptic operation involves protection against contamination and it is a well established and understood concept in the fermentation industries, whereas con tainment involves prevention of escape of viable cells from a fermenter or downstream equipment and is much more recent in origin. Containment guidelines were initiated during the 1970s (East et al, 1984; Flickinger and Sansone, 1984).
To establish the appropriate degree of containment which will be necessary to grow a micro-organism, it, and in fact the entire process, must be carefully assessed for potential hazards that could occur should there be accidental release. Different assessment procedures are used depending on whether or not the organism contains foreign DNA (genetically engineered). Once the hazards are assessed, an organism can be classified into a hazard group for which there is an appropriate level of containment. The procedure which has been adopted within the European Community is outlined in Fig. 7.3. Non-genetically engineered organisms may be placed into a hazard group (1 to 4) using criteria to assess risk such as those given by Collins (1992):
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